Attachment D.2 - Sole Source Justification (Brand Name) InnoWave Pro Sonic Irrigator - Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 3

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 (BRAND NAME)

Acquisition Plan Action ID:

Requisition Number:

1. Contracting Activity:

Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) located at 5075 Westheimer Road, Suite 750, Houston, TX 77056.

2. Nature and/or Description of the Action Being Processed

The Michael E. DeBakey VA Medical Center (MEDVAMC) Clinicial practice Office/Sterile Processing Services (SPS) department is seeking purchase a brand name InnoWave Pro Sonic Irrigator (60 Lumens) system.

The InnoWave Pro offers Sonic Irrigation technology which exposes both the instruments external surfaces and internal channels (if connected) to ultrasonic activity. The InnoWave Pro offers multiple cycle phases like pre-wash, wash, disinfection, and rinse phases. The InnoWave Pro is also enabled with an air-purge phase to assist with drying.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

MEDVAMC is requesting a brand name only InnoWave Pro Sonic Irrigator (60 Lumens). The MEDVAMC is currently using the Steris InnoWave Sonic Cleaner for continuity of care to support the existing Standard Operating Procedure (SOP) and eliminate the process of creating new Instructions For Use (IFU). Also it would eliminate the need to create a new compentancy for the employees to get certified to operated the equipment. The need to use a different brand and model would take man hours in training on a new brand and model that can be used to reprocess scopes.

Compatibility is required to support possibility of having to purchase additional attachments for the various scopes to a different brand and model.

InnoWave Pro Sonic Irrigator (60 Lumens) should include:

InnoWave Pro Sonic Irrigator (60 Lumens) Eliminzer Combo – Dryer/Filter Filter Second Stage (Pre-Filter) Filter First Stage (Drying) Pro Xi Basket & Hose Set for 6 Standard Xi InnoWave Pro Xi Basket and Hose Set for 6 Standard Xi Endowrists Install InnoWave PRO Deinstall InnoWave PRO Disposal of Washer 1st Year Preventive Care InnoWave PRO

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4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

MEDVAMC SPS department needs the InnoWave Pro Sonic Irrigator (60 Lumens) system for continuity of care, seamless implementation thus reducing the amount of startup time, training, and elimination of human errors. Furthermore, the system will support the immediate need the on going operations and workflow of the SPS department. Due to these facts, brand name only InnoWave Pro Sonic Irrigator (60 Lumens) system is required. If name brand only was not used for this portion of the requirement, Veteran health would be impacted due to delays of training employees to get certified to operated the equipment. The need to use a different brand and model which would affect patient safety.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A sources sought notice 36C25623Q0821 was posted on the Governmentwide Point of Entry (GPE) Contract Opportunities on 04-26-2023 and closed on 05-01-2023. The intent of the notice was to determine the availability of sources regarding who would be interested and capable in providing the InnoWave Pro Sonic Irrigator (60 Lumens) system. Due to the issuance of the sources sought, a total of two responses was received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The CO anticipated cost will be considered fair and reasonable. The steps that will be taken to ensure the final contract price will be fair and reasonable are also described here. The estimated market research pricing provided with the sources sought responses was found to be consistent with the Independent Government Cost Estimate (IGCE). Additionally, price competition is expected for this action.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

In addition to the sources sought notice; market research was conducted by database queries to GSA eLibrary, SBA’s DSBS, VetCert, and Google.

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Based upon the market research and through sources sought notuce there is reasonable expectation that offers/quotations will be received from two or more eligible VetCert listed SDVOSBs and award can be made at a fair and reasonable price that offers the best value to the Government. The brand name justification will be posted with the solicitation on GPE Contract Opportunities in accordance with FAR 5.102(a)(6).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Continuing to use the same brand of InnoWave Pro Sonic Irrigator (60 Lumens) system will allow for the shortest activation time frame and result in a timely and positive impact on patient care.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

The agency will continuously monitor the market to keep pace with the agency’s needs; as well as to identify the latest technologies, compatible products and systems, new manufacturers, and market prices to support future competition of this requirement and support patient care.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Date

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Date